Do any of you is complying with FDA 21 CFR part 11 using RTC?

Alvaro Riera

(40●2●14●18) Nov 04 '13, 5:55 a.m.

Morning, i have an RTC doubt.

We need to comply with FDA 21 CFR part 11 in one of our projects.

I have configured RTC e-signature to request password in state changes and in aprovals, reviews, etc...

Just wanna know if its enough to comply with FDA 21 CFR part 11 based in your experience :)

Tyvm.

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Paul Spalitta

Oct 12 '15, 9:26 p.m.

Did you finish qualifying RTC as 21 CFR Part 11 compliant?

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Question asked: Nov 04 '13, 5:55 a.m.

Question was seen: 3,931 times

Last updated: Oct 12 '15, 9:26 p.m.

Do any of you is complying with FDA 21 CFR part 11 using RTC?

Alvaro Riera

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Paul Spalitta

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3,931 views

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